CLOSM Trial: Groin Closure Using Layered Option for Suture Material

Description

This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl suture versus PDS (polydioxanone) suture. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.

Conditions

Vascular Diseases

Study Overview

Study Details

Study overview

This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl suture versus PDS (polydioxanone) suture. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.

CLOSM Trial: Groin Closure Using Layered Option for Suture Material

CLOSM Trial: Groin Closure Using Layered Option for Suture Material

Condition
Vascular Diseases
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * All patients \> 18 years who undergo ELECTIVE vascular surgery that would require groin incisions
  • * Patients with to undergo ELECTIVE bilateral groin incisions will be matched to receive closure with PDS in one groin and Vicryl in the other groin
  • 1. Age 17 or younger
  • 2. Prisoners
  • 3. Pregnant patients
  • 4. Emergent cases
  • 5. Active groin infection prior to intervention
  • 6. History of prior surgical groin access (re-operative groin)
  • 7. Groin closure after extracorporeal membrane oxygenation (ECMO)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Francis Caputo, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2027-12-31